Job Description

• Develop and manage project plans using MS Project / OnePlan.
• Drive project execution from initiation through change notifications (Project Charter, ECR).
• Manage change control and design planning through CCP/DDP/PEGA.
• Coordinate engineering changes for Cost to Win, Line Extension, Quality Improvement, Labeling & Packaging, Supplier Validation, Regulatory Compliance.
• Support design transfer activities and Design History File audits.
• Oversee creation and updates of design control documents (Design Inputs, Traceability Matrix, Specifications, Verification Plans, Protocols & Reports, FMEA).
• Gather requirements and responses from cross-functional teams.
• Coordinate with teams for Design Verification Testing and Process Validation (IQ/OQ/PQ).
• Manage transactions in PLM tools (MasterControl, PEGA).
• Prepare project status reports, risk assessments, and obsolescence reports.
• Conducting periodic Review with core team members and update the project status update to Client portfolio manager.

Required Skills

• Strong Project Management skills with experience in regulated industries.
• Basic R&D and Engineering knowledge (Mechanical/Electrical).
• Proficiency in MS Project (MPP) and MS Office Suite.
• Familiarity with tools like SolidWorks, AutoCAD, Minitab (statistical analysis).
• Excellent communication and stakeholder management skills.
• Cross-functional coordination and collaboration skills.
• Qualifications
• Bachelor’s degree in mechanical engineering.
• 10+ years of experience in Project Management, preferably in Medical Devices or regulated industry.
• Knowledge of ISO 13485 / QSR 21 CFR Part 820 is an advantage.

Tools & Systems: MS Project, MasterControl, PEGA, OnePlan, SolidWorks, AutoCAD, Minitab

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